Label: COLD RELIEF MULTI-SYMPTOM- acetaminophen, chlorpheniramine maleate, dextromethorphan hbr, phenylephrine hcl kit
- NDC Code(s): 50844-529-09
- Packager: L.N.K. International, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated August 17, 2023
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- Official Label (Printer Friendly)
- Active ingredients (in each caplet) (Daytime Cold Multi-Symptom)
- Purpose
- Active ingredients (in each caplet) (Nighttime Cold Multi-Symptom)
- Purpose
-
Uses
- temporarily relieves these common cold and flu symptoms:
- cough
- headache
- sore throat
- nasal congestion
- minor aches and pains
- sinus congestion and pressure
- sneezing and runny nose (Nighttime only)
- helps clear nasal passages
- promotes nasal and sinus drainage
- relieves cough to help you sleep
- temporarily reduces fever
- temporarily relieves these common cold and flu symptoms:
-
Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take
- more than 4,000 mg of acetaminophen in 24 hours
- with other drugs containing acetaminophen
- 3 or more alcoholic drinks every day while using this product
Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:
- skin reddening
- blisters
- rash
If a skin reaction occurs, stop use and seek medical help right away.
Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.
Do not use
- with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
- if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
- if you have ever had an allergic reaction to this product or any of its ingredients
Ask a doctor before use if you have
- diabetes
- liver disease
- high blood pressure
- heart disease
- glaucoma (Nighttime only)
- cough that occurs with too much phlegm (mucus)
- persistent or chronic cough such as occurs with smoking, asthma, or emphysema
- difficulty in urination due to enlargement of the prostate gland
- thyroid disease
- a breathing problem such as emphysema or chronic bronchitis (Nighttime only)
Ask a doctor or pharmacist before use if you are
- taking the blood thinning drug warfarin
- taking sedatives or tranquilizers (Nighttime only)
When using this product
- do not exceed recommended dosage
- excitability may occur, especially in children (Nighttime only)
- marked drowsiness may occur (Nighttime only)
- avoid alcoholic beverages (Nighttime only)
- use caution when driving a motor vehicle or operating machinery (Nighttime only)
- alcohol, sedatives, and tranquilizers may increase drowsiness (Nighttime only)
Stop use and ask a doctor if
- nervousness, dizziness, or sleeplessness occur
- pain, nasal congestion, or cough gets worse or lasts more than 7 days
- new symptoms occur
- fever gets worse or lasts more than 3 days
- redness or swelling is present
- cough comes back or occurs with rash or headache that lasts. These could be signs of a serious condition.
- Directions
- Other information
- Inactive ingredients (Daytime only)
- Inactive ingredients (Nighttime only)
- Questions or comments?
-
Principal Display Panel
QUALITY
+PLUSNDC 50844-529-09
MULTI-SYMPTOM
COLD RELIEFAcetaminophen,
Dextromethorphan HBr,
Phenylephrine HClPAIN RELIEVER/FEVER REDUCER,
COUGH SUPPRESSANT,
NASAL DECONGESTANTACTUAL
SIZE12 Caplets
Acetaminophen,
Chlorpheniramine maleate,
Dextromethorphan HBr,
Phenylephrine HClPAIN RELIEVER/FEVER REDUCER,
ANTIHISTAMINE,
COUGH SUPPRESSANT,
NASAL DECONGESTANTACTUAL
SIZE8 Caplets
20 Total Caplets
TAMPER EVIDENT: DO NOT USE IF PACKAGE IS
OPENED OR IF BLISTER UNIT IS TORN, BROKEN
OR SHOWS ANY SIGNS OF TAMPERINGPARENTS:
Learn about teen medicine abuse
www.StopMedicineAbuse.orgDo Not Take Daytime and
Nighttime Products at the
Same Time.50844 ORG112247047309
Distributed by
LNK INTERNATIONAL, INC.
60 Arkay Drive
Hauppauge, NY 11788
USAQuality Plus 44-470C473C
-
INGREDIENTS AND APPEARANCE
COLD RELIEF MULTI-SYMPTOM
acetaminophen, chlorpheniramine maleate, dextromethorphan hbr, phenylephrine hcl kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:50844-529 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:50844-529-09 1 in 1 CARTON; Type 0: Not a Combination Product 07/21/2005 Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 1 BLISTER PACK 12 Part 2 1 BLISTER PACK 8 Part 1 of 2 COLD RELIEF DAYTIME
acetaminophen, dextromethorphan hbr, phenylephrine hcl tablet, film coatedProduct Information Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 325 mg DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 10 mg PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 5 mg Inactive Ingredients Ingredient Name Strength STARCH, CORN (UNII: O8232NY3SJ) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) CROSPOVIDONE, UNSPECIFIED (UNII: 2S7830E561) MAGNESIUM STEARATE (UNII: 70097M6I30) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990) POVIDONE, UNSPECIFIED (UNII: FZ989GH94E) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) STEARIC ACID (UNII: 4ELV7Z65AP) SUCRALOSE (UNII: 96K6UQ3ZD4) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color white Score no score Shape OVAL Size 17mm Flavor MENTHOL Imprint Code 44;470 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 12 in 1 BLISTER PACK; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M012 07/15/2005 Part 2 of 2 COLD RELIEF NIGHTTIME
acetaminophen, chlorpheniramine maleate, dextromethorphan hbr, phenylephrine hcl tablet, film coatedProduct Information Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 325 mg CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U) CHLORPHENIRAMINE MALEATE 2 mg DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 10 mg PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 5 mg Inactive Ingredients Ingredient Name Strength STARCH, CORN (UNII: O8232NY3SJ) CROSPOVIDONE, UNSPECIFIED (UNII: 2S7830E561) FD&C BLUE NO. 1 ALUMINUM LAKE (UNII: J9EQA3S2JM) FD&C BLUE NO. 2 ALUMINUM LAKE (UNII: 4AQJ3LG584) MAGNESIUM STEARATE (UNII: 70097M6I30) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990) POVIDONE, UNSPECIFIED (UNII: FZ989GH94E) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2) STEARIC ACID (UNII: 4ELV7Z65AP) SUCRALOSE (UNII: 96K6UQ3ZD4) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color blue Score no score Shape OVAL Size 17mm Flavor MENTHOL Imprint Code 44;473 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 8 in 1 BLISTER PACK; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M012 07/21/2005 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M012 07/21/2005 Labeler - L.N.K. International, Inc. (038154464) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 832867837 manufacture(50844-529) , pack(50844-529) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 832867894 manufacture(50844-529) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 117025878 manufacture(50844-529)